Generic Drugs: The Global Market

Table of Contents

Chapter- 1: INTRODUCTION -- Complimentary

• STUDY GOALS AND OBJECTIVES 1
• REASONS FOR DOING THE STUDY 1
• SCOPE OF REPORT 2
• MARKET ANALYSES AND FORECASTS 2
• METHODOLOGY 2
• INTENDED AUDIENCE 2
• INFORMATION SOURCES 3
• ANALYST CREDENTIALS 3
• RELATED REPORTS 3
• BCC ONLINE SERVICES 3
• DISCLAIMER 4

Chapter-2: SUMMARY 4

• SUMMARY 5
• MARKET SIZE AND EVOLUTION 6
• SUMMARY TABLE MAJOR NATIONAL GENERIC MARKETS ($ BILLIONS) 7
• SUMMARY FIGURE LEADING COMPANIES, SHARE OF WORLD GENERIC MARKET (%) 8

Chapter-3: OVERVIEW 7

• INTRODUCTION AND BRIEF HISTORY 9
• MODERN PHARMACEUTICAL ERA 10
• REGULATORY ASPECTS 11
• GENERICS LOBBY 12
• GENERICS LOBBY (CONTINUED) 13
• THE PRESENT GENERIC LANDSCAPE 14
• THE PRESENT GENERIC LANDSCAPE (CONTINUED) 15

Chapter-4: GENERIC PRODUCT CATEGORIES 10

• ' SIMPLE' GENERICS 16
• ADEQUATE MARKET SIZE 16
• PATENT-EXPIRED THERAPIES 16
• OLDER PRODUCTS STILL USED 17
• LONG-TERM USE 17
• STRAIGHTFORWARD PRODUCTION TECHNOLOGY 18
• DRUGS USED IN PRIMARY CARE 18
• SUPERGENERICS 19
• BIOSIMILARS 19
• SPECIAL CHALLENGES 20
• Special Challenges (Continued) 21
• TABLE 1 COMPANIES INVOLVED IN BIOSIMILAR R&D 22
• Biosimilars Market 23
• TABLE 2 MARKET OPPORTUNITIES FOR BIOSIMILARS 24
• Biosimilars Market (Continued) 25

Chapter-5: MARKET OPPORTUNITIES BY PRODUCT CLASS 27

• LEADING GENERIC MOLECULES 26
• TABLE 3 WIDELY PRESCRIBED GENERIC MOLECULES IN U.S. AND EUROPE 26
• ANTI-INFECTIVES 27
• TABLE 4 LEADING ANTI-INFECTIVE PRODUCTS IN 2008 SALES ESTIMATES ($ BILLIONS) 28
• TABLE 5 GENERIC ANTI-INFECTIVES MARKET SALES FORECAST, 2009 - 2014 ($ BILLIONS) 29
• CNS THERAPIES 29
• FIGURE 1 MAJOR DIVISIONS OF CNS MARKET, 2008 % 30
• ANTIDEPRESSANTS 30
• ANTIPSYCHOTICS 31
• TABLE 6 LEADING CNS PRODUCTS SALES ESTIMATES, 2008 ($ BILLION) 32
• ANXIOLYTICS 32
• SLEEP DISORDERS 33
• EPILEPSY 33
• PARKINSON' S DISEASE 34
• MIGRAINE 35
• TABLE 7 GENERIC CNS PRODUCTS MARKET FORECAST, THROUGH 2014 ($ BILLIONS) 35
• CARDIOVASCULAR PRODUCTS 35
• CARDIOVASCULAR PRODUCTS (CONTINUED) 36
• TABLE 8 LEADING CARDIOVASCULAR PRODUCTS, 2008 (SALES ESTIMATES IN $ BILLION) 37
• TABLE 9 GENERIC CARDIOVASCULAR PRODUCTS MARKET FORECAST THROUGH 2014 ($ BILLIONS) 38
• ANTI-ARTHRITIS PRODUCTS 38
• STEROIDS 39
• NSAIDS 39
• COX-II INHIBITORS 39
• DMARDS 40
• TABLE 10 ESTIMATED SALES OF LEADING ANTI-ARTHRITIS PRODUCTS, 2008 ($ BILLIONS) 41
• TABLE 11 GENERIC ANTI-INFLAMMATORY PRODUCTS MARKET FORECAST, THROUGH 2014 ($ BILLIONS) 42
• RESPIRATORY PRODUCTS 42
• ASTHMA 42
• COPD 43
• ALLERGIC RHINITIS 43
• Allergic Rhinitis (Continued) 44
• TABLE 12 ESTIMATED SALES OF LEADING RESPIRATORY PRODUCTS, 2008 ($ BILLIONS) 45
• DRUGS USED IN ASTHMA AND COPD 46
• Bronchodilators 46
• Inhaled Bronchodilators 46
• Anticholinergics 46
• Oral Bronchodilators 47
• Leukotriene Antagonists 47
• Steroids 47
• FIGURE 2 ASTHMA MARKET - MAJOR PRODUCT CATEGORIES, 2008 % 48
• TABLE 13 GENERIC RESPIRATORY PRODUCTS MARKET FORECAST 2009 - 2014 ($ BILLIONS) 49
• ANTICANCER PRODUCTS 49
• CYTOTOXIC DRUGS 49
• HORMONAL THERAPY 49
• BIOLOGIC RESPONSE MODIFIERS 50
• ANTIANGIOGENESIS DRUGS 50
• MONOCLONAL ANTIBODIES 50
• TABLE 14 ESTIMATED SALES OF LEADING RESPIRATORY PRODUCTS, 2008 ($ BILLIONS) 51
• TABLE 15 GENERIC ANTICANCER PRODUCTS MARKET FORECAST, THROUGH 2014 ($ BILLIONS) 52

Chapter-6: GLOBAL AND NATIONAL MARKETS 39

• THE GLOBAL PHARMACEUTICAL MARKET 53
• GLOBAL GENERIC MARKET 53
• LEADING NATIONAL MARKETS 54
• THE GENERIC INDUSTRY 54
• TABLE 16 REVENUE DATA AND MARKET SHARES, BY COM PANY, 2008 54
• TRENDS 55
• NORTH AMERICA 55
• U.S. 55
• Market Size and Growth 55
• Recent Trends 56
• Generic Prices 56
• The U.S. Generics Industry 57

• FIGURE 3 LEADING U.S. GENERIC COMPANIES SALES, 2008 ($ BILLIONS) 57
• The Future 58
• TABLE 17 U.S. GENERICS MARKET, THROUGH 2014 ($ BILLIONS) 58
• FIGURE 4 U.S. GENERICS MARKET, 2006-2014 ($ BILLIONS) 59
• CANADA 59
• Canada (continued) 60
• TABLE 18 CANADIAN GENERICS MARKET, THROUGH 2014 $ BILLIONS 61
• FIGURE 5 CANADIAN GENERICS MARKET, 2006-2014 ($ BILLIONS) 61
• EUROPE 62
• FRANCE 62
• France (Continued) 63
• TABLE 19 GENERICS MARKET IN FRANCE, THROUGH 2014 ($ BILLIONS) 64
• FIGURE 6 GENERICS MARKET IN FRANCE, THROUGH 2014 ($ BILLIONS) 64
• GERMANY 64
• TABLE 20 GENERICS MARKET IN GERMANY, THROUGH 2014 ($ BILLIONS) 65
• FIGURE 7 GENERICS MARKET IN GERMANY, 2006-2014 ($ BILLIONS) 66
• ITALY 66
• TABLE 21 GENERICS MARKET IN ITALY, THROUGH 2014 ($ BILLIONS) 67
• FIGURE 8 GENERICS MARKET IN ITALY, 2006-2014 ($ BILLIONS) 68
• SPAIN 68
• Spain (Continued) 69
• TABLE 22 GENERICS MARKET IN SPAIN, THROUGH 2014 ($ BILLIONS) 70
• FIGURE 9 GENERICS MARKET IN SPAIN, 2006-2014 ($ BILLIONS) 70
• UNITED KINGDOM 70
• TABLE 23 GENERICS MARKET IN UNITED KINGDOM, THROUGH 2014 ($ BILLIONS) 71
• FIGURE 10 GENERICS MARKET IN UNITED KINGDOM, 2006-2014 ($ BILLIONS) 72
• LATIN AMERICA 72
• BRAZIL 73
• Brazil (Continued) 74
• TABLE 24 GENERICS MARKET IN BRAZIL, THROUGH 2014 ($ BILLIONS) 75
• FIGURE 11 GENERICS MARKET IN BRAZIL, 2006-2014 ($ BILLIONS) 75
• MEXICO 76
• TABLE 25 GENERICS MARKET IN MEXICO, THROUGH 2014 ($ BILLIONS) 77
• FIGURE 12 GENERICS MARKET IN MEXICO, 2006 2014 ($ BILLIONS) 78
• ASIA 78
• JAPAN 78
• Japan (Continued) 79
• Japan (Continued) 80
• TABLE 26 GENERICS MARKET IN JAPAN, THROUGH 2014 ($ BILLIONS) 81
• FIGURE 13 GENERICS MARKET IN JAPAN, 2006-2014 ($ BILLIONS) 81
• INDIA 82
• Patent Reform 82
• Generic Industry 83
• TABLE 27 SALES IN INDIA OF LOCAL AND FOREIGN COMPANIES, 2008 ($ MILLIONS) 83
• TABLE 28 GENERICS MARKET IN INDIA, THROUGH 2014 ($ BILLIONS) 84
• FIGURE 14 GENERICS MARKET IN INDIA, 2006-2014 ($ BILLIONS) 84
• CHINA 85
• Domestic Industry 86
• Foreign Company Involvement 87
• Market Trends 88
• Generic Exports 89
• TABLE 29 GENERICS MARKET IN CHINA, THROUGH 2014 ($ BILLIONS) 90
• FIGURE 15 GENERICS MARKET IN CHINA, 2006-2014 ($ BILLIONS) 91

Chapter-7: REGULATORY AND PATENT ASPECTS 19

• STRUCTURE OF THE GENERICS INDUSTRY 111
• COMPANY PROFILES 112
• ACTAVIS 112
• ALAPIS 113
• AMNEAL 114
• APOTEX 115
• Apotex (Continued) 116
• ASPEN 117
• Products 117
• Financials 118
• AUROBINDO 118
• Products 119
• Financials 119
• Looking Ahead 120
• BARR 120
• Financials 121
• BERLIN CHEMIE 121
• BIOCON 122
• Products 123
• Financials 124
• BIOGARAN 124
• Financials 125
• Looking Ahead 125
• CIPLA 126
• Financials 127
• COBALT 127
• Products 127
• DR REDDY' S 128
• Products 129
• Acquisitions 129
• Financials 129
• Looking Ahead 130
• EGIS 130
• APIs 131
• Pharmaceutical R&D 131
• Sales of Finished Products and Active Pharmaceutical Ingredients 131
• Products 131
• Products 132
• Financials 133
• TABLE 31 EGIS THIRD-QUARTER SALES, 2007 AND 2008 133
• GEDEON RICHTER 133
• Products 134
• Financials 134
• TABLE 32 GEDEON RICHTER' S TOPLINE RESULTS FOR 2008, FULL YEAR 135
• Looking Ahead 135
• GENEPHARM 135
• Products 136
• HOSPIRA 137
• Biogenerics 138
• Financials 138
• IVAX 139
• KRKA 140
• Products 140
• Financials 141
• Looking Ahead 141
• LUPIN 142
• LUPIN LTD. 142
• Financials 143
• MERCK GENERICS 144
• MYLAN 144
• Mylan (Continued) 145
• Financials 146
• Looking Ahead 146
• NICHI-IKO NICHI-IKO PHARMACEUTICAL CO., LTD. 147
• Products 147
• Financials 148
• Looking Ahead 148
• NIPPON-CHEMIPHAR 148
• Financials 149
• Looking Ahead 149
• NOVARTIS 149
• Financials 150
• Looking Ahead 151
• Products 151
• Products 152
• Financials 152
• Looking Ahead 152
• PAR 152
• Products 153
• Financials 153
• PFIZER 154
• TABLE 33 MAIN PRODUCTS COMING OFF-PATENT, 2010-2021 155
• Products 155
• Financials 155
• Products 156
• Financials 157
• RANBAXY 157
• History 157
• Acquisition by Daiichi Sankyo 158
• Financials 159
• Looking Ahead 159
• ROXANE 160
• SANDOZ 161
• Products 161
• SANOFI-AVENTIS 162
• Financials 163
• Looking Ahead 163
• SAWAI 164
• Products 164
• Financials 165
• Looking Ahead 165
• STADA 165
• Generics 166
• Biosimilars 166
• Financials 166
• Looking Ahead 167
• STRIDES 167
• Products 168
• Financials 169
• Looking Ahead 169
• TANABE SEIYAKU HANBAI 169
• Looking Ahead 170
• TEVA 170
• TEVA (Continued) 171
• Financials 172
• Looking Ahead 172
• WATSON 172
• Products 173
• Financials 173
• Looking Ahead 174
• WOCKHARDT 174
• Financials 175
• Looking Ahead 175
• ZYDUS CADILA 176
• Products 177
• Financials 177

APPENDIX I: FURTHER READING 178

• FURTHER READING (CONTINUED) 179

APPENDIX II: GLOSSARY OF ACRONYMS 180